Safety cases

Overview

A safety case is a valuable tool for bringing about a systematic approach to safety and for providing a record of management’s commitment to safety.

Over the past decade, European industry has moved markedly away from a regulatory approach of assuring system safety involving prescriptive codes and standards towards one where it is the responsibility of operators to present a sound argument that systems achieve acceptable safety standards. These arguments and their supporting evidence have become known as ‘the safety case’. A safety case should communicate a clear, comprehensive and defensible argument that a system is acceptably safe to operate in a particular context.

There have been some attempts to introduce safety cases in health care, including for medical devices promoted by the US Food & Drug Association. 

What we’re doing

We have commissioned a group of researchers, led by Warwick University, to conduct pragmatic rapid reviews on the use of safety cases in safety-critical industries. Authors will use a common structure for each industry study, for example:

• how long have safety cases been in use in this domain?
• what does the regulatory context look like?
• what are the main benefits and challenges associated with safety cases in this domain?
• what are the main lessons learned for other domains and for health?

A second stage to the project will consist of a pragmatic literature review of how safety cases have been applied in health care, the findings of which will be considered by industry and health care experts. 

Why we’re doing it

The Health Foundation’s Safer Clinical Systems (SCS) programme is an overall approach to building a safer system through redesigning and managing core clinical support processes in order to reduce risk of harm. The approach involves training and tools that will be used by each award holder in their local context. Each organisation will use the knowledge and expertise to work out the specifics of the local problem and to develop targeted interventions (some of which will be already tested solutions).

In 2011 we will roll out Phase 2 of the programme, which is being designed as a testing and innovation phase. Within the parameters we have set, the organisations will be able to diagnose their own safety issues (and identify appropriate improvements) with keen attention to processes.

Within the first phase of the SCS programme the safety case concept was introduced as a way of structuring thinking around patient safety and as a means of integrating different sources of evidence (both quantitative and qualitative). 

The safety case approach is already a well used diagnostic and improvement tool in other industries. Organisations in the phase 2 of SCS will be encouraged to test this (and other tools) to build safer clinical systems.  

This research will inform phase 2 of SCS by providing:   

• a clear description of safety case use in selected safety-critical industries
• pragmatic recommendations for the adoption of safety cases in healthcare
• outlines of possible healthcare application scenarios.

How we’re doing it

We apply a rigorous but pragmatic methodology that is scientifically defensible but is broadly inclusive, especially where the evidence base is not strong.

When will the findings be available?

Spring 2012

For further information please contact:

Jonathan Bamber, Research and Development Manager